Sleep QualityNCT05715294
The Effect of Music on Sleep Quality in Behçet's Patients
A study testing Music Application in people with Sleep Quality and Behçet Disease, run by Gazi University.
Trial summary
The aim of this study was to evaluate effect of music on sleep quality in patients with Behçet's disease. The population of the study consists of behçet patients who applied to the Rheumatology outpatient clinic of Medical Faculty Hospital, who met the research criteria and agreed to participate in the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Behçet Disease
- What is being tested?
- Music Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older Having been diagnosed with Behçet's Disease for at least 6 months A score of 0-25 on the Richard-Campbell Sleep Questionnaire No visual or hearing impairment Being literate Ability to understand and speak Turkish Having mental and cognitive competence Not having a psychiatric diagnosis It is voluntary to participate in the study. Not using sleeping pills Become an Android processor phone
- -
Who cannot join
- Unreachable during phone calls with sleep apnea Chronic diseases that can affect sleep such as COPD, Asthma, Heart failure not continuing research Patients using sleeping pills
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: TC Gazi University
The aim of this study was to evaluate effect of music on sleep quality in patients with Behçet's disease. The population of the study consists of behçet patients who applied to the Rheumatology outpatient clinic of Medical Faculty Hospital, who met the research criteria and agreed to participate in the study.
The study will conduct in a randomized controlled experimental design with two groups. The sample of the study will be 50 behçet patients the music practice group (25) and the control group (25). The research will be carried out between December 2022 and December 2023. In this study, data will with collect Descriptive Information Form, Behçet's Syndrome Activity Scale (BSAS) and Richard-Campbell Sleep Scale (RCUI).
Read the detailed description
This study will be conducted as a parallel group randomized controlled experimental study to determine the effect of listening to music in the uşşak makam on sleep quality in Behçet's Diseases.The population of the research will be Behçet's patients receiving outpatient treatment in the Rheumatology outpatient clinic of a university hospital.G.Power program was used to calculate the sample size of the study. In descriptive studies, the t tests - Means: Difference between two independent means (two groups) model was used to determine the sample size when the number of individuals in the universe was not known. While determining the sample volume in the research, the test for the main hypothesis was determined at the first stage and the required averages were obtained from Bakır's research in 2019, which is compatible with our study in the literature (Bakır, 2019). According to the g-power analysis, with 95% confidence level and α=0.05 margin of error, it has an effect size of 0.941 and a tolerance ratio of 5%; In this study, the power of the test was determined as p: 0.05, (1-β): 90%, t = 2.015, and in line with this information, it was concluded that the number of samples required for the study was 46 people in both groups. Considering the possible losses from the experimental study, the number of samples was increased by 10% and it was decided that the total sample size would be 50 people, 25 people in the intervention group and 25 people in the control group.Application In this study, intervention and control groups will be studied in a pre-test and post-test design. No intervention will be applied to the control group. Passive music listening practice for the intervention group.
- Conditions
- Sleep Quality, Behçet Disease
- Being tested
- Music Application
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ApplicationOther
A music CD was prepared within the scope of passive music listening practice. To determine the music, the researcher advice and literature knowledge of Turkish Music A music CD was prepared within the scope of passive music listening practice. To determine the music, the researcher advice and literature knowledge of Turkish Music Research and Promotion Society (TUMATA) was used. In the music application, the selecting instrumental music (ussak maqam which is Turkish Music Maqam) was used. The prepared Music CD will be played on the phones of patients with android processor phones. Patients will be told that they should listen to the music lying down and in a comfortable position, and that they should not use headphones while listening to music. Before going to bed, the patients will be listened to music composed in Ussak maqam for 50 minutes every day for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Music Application Group | Experimental | After explaining the purpose of the study and the way it was applied to behçet's patients in the music group, Introductory Information Form, Behçet's Syndrome Activity Scale (BSAS), Richards-Campbell Sleep Questionnaire (RCSQ) will be applied. Patients will listen to music composed in Uşşak makam for 50 minutes before going to bed every day for 7 days. After the first interview, the patients will be reminded of the music application by phone call and 2 text messages every day by the researcher. Interviews will be recorded on the Patient's Telephone Follow-up Form while Listening to Music. On the 8th day, the BSAS and RCSQ scales will be reapplied to the patients in the intervention group. Receives: Other: Music Application |
| Control Group | No intervention | After explaining the purpose of the study and the way it was applied to behçet's patients in the control group, Introductory Information Form, Behçet's Syndrome Activity Scale (BSAS), Richards-Campbell Sleep Questionnaire (RCSQ) will be applied.No application will be made to the control group. On the 8th day, the BSAS and RCSQ scales will be reapplied to the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richard - Campbell Sleep Questionnaire
Scores from the scale range from 0 to 100, and the higher the score, the higher the sleep quality. "0-25" points poor sleep quality, "76-100" points good sleep quality.
Measured: a day before the music application
Richard - Campbell Sleep Questionnaire
Scores from the scale range from 0 to 100, and the higher the score, the higher the sleep quality. "0-25" points poor sleep quality, "76-100" points good sleep quality.
Measured: after music application, 8th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start30 Jan 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Canbolat, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715294
- Sponsor's protocol ID
- Ozlem Canbolat
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TC Gazi University
- ClinicalTrials.gov ID
- NCT05715294
- Acronym / sponsor ID
- Ozlem Canbolat
- Conditions
- Sleep Quality, Behçet Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate effect of music on sleep quality in patients with Behçet's disease. The population of the study consists of behçet patients who applied to the Rheumatology outpatient clinic of Medical Faculty Hospital, who met the research criteria and agreed to participate in the study.
The study will conduct in a randomized controlled experimental design with two groups. The sample of the study will be 50 behçet patients the music practice group (25) and the control group (25). The research will be carried out between December 2022 and December 2023. In this study, data will with collect Descriptive Information Form, Behçet's Syndrome Activity Scale (BSAS) and Richard-Campbell Sleep Scale (RCUI).
Detailed description
This study will be conducted as a parallel group randomized controlled experimental study to determine the effect of listening to music in the uşşak makam on sleep quality in Behçet's Diseases.The population of the research will be Behçet's patients receiving outpatient treatment in the Rheumatology outpatient clinic of a university hospital.G.Power program was used to calculate the sample size of the study. In descriptive studies, the t tests - Means: Difference between two independent means (two groups) model was used to determine the sample size when the number of individuals in the universe was not known. While determining the sample volume in the research, the test for the main hypothesis was determined at the first stage and the required averages were obtained from Bakır's research in 2019, which is compatible with our study in the literature (Bakır, 2019). According to the g-power analysis, with 95% confidence level and α=0.05 margin of error, it has an effect size of 0.941 and a tolerance ratio of 5%; In this study, the power of the test was determined as p: 0.05, (1-β): 90%, t = 2.015, and in line with this information, it was concluded that the number of samples required for the study was 46 people in both groups. Considering the possible losses from the experimental study, the number of samples was increased by 10% and it was decided that the total sample size would be 50 people, 25 people in the intervention group and 25 people in the control group.Application In this study, intervention and control groups will be studied in a pre-test and post-test design. No intervention will be applied to the control group. Passive music listening practice for the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Application Group | Experimental | Other: Music ApplicationAfter explaining the purpose of the study and the way it was applied to behçet's patients in the music group, Introductory Information Form, Behçet's Syndrome Activity Scale (BSAS), Richards-Campbell Sleep Questionnaire (RCSQ) will be applied. Patients will listen to music composed in Uşşak makam for 50 minutes before going to bed every day for 7 days. After the first interview, the patients will be reminded of the music application by phone call and 2 text messages every day by the researcher. Interviews will be recorded on the Patient's Telephone Follow-up Form while Listening to Music. On the 8th day, the BSAS and RCSQ scales will be reapplied to the patients in the intervention group. |
| Control Group | No intervention | –After explaining the purpose of the study and the way it was applied to behçet's patients in the control group, Introductory Information Form, Behçet's Syndrome Activity Scale (BSAS), Richards-Campbell Sleep Questionnaire (RCSQ) will be applied.No application will be made to the control group. On the 8th day, the BSAS and RCSQ scales will be reapplied to the patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older Having been diagnosed with Behçet's Disease for at least 6 months A score of 0-25 on the Richard-Campbell Sleep Questionnaire No visual or hearing impairment Being literate Ability to understand and speak Turkish Having mental and cognitive competence Not having a psychiatric diagnosis It is voluntary to participate in the study. Not using sleeping pills Become an Android processor phone
- -
Key exclusion criteria (2 listed)
- Unreachable during phone calls with sleep apnea Chronic diseases that can affect sleep such as COPD, Asthma, Heart failure not continuing research Patients using sleeping pills
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music ApplicationA music CD was prepared within the scope of passive music listening practice. To determine the music, the researcher advice and literature knowledge of Turkish Music A music CD was prepared within the scope of passive music listening practice. To determine the music, the researcher advice and literature knowledge of Turkish Music Research and Promotion Society (TUMATA) was used. In the music application, the selecting instrumental music (ussak maqam which is Turkish Music Maqam) was used. The prepared Music CD will be played on the phones of patients with android processor phones. Patients will be told that they should listen to the music lying down and in a comfortable position, and that they should not use headphones while listening to music. Before going to bed, the patients will be listened to music composed in Ussak maqam for 50 minutes every day for 7 days. | Other | Music Application Group |
Primary outcome
Richard - Campbell Sleep Questionnaire
Time frame: a day before the music application
Scores from the scale range from 0 to 100, and the higher the score, the higher the sleep quality. "0-25" points poor sleep quality, "76-100" points good sleep quality.
Richard - Campbell Sleep Questionnaire
Time frame: after music application, 8th day
Scores from the scale range from 0 to 100, and the higher the score, the higher the sleep quality. "0-25" points poor sleep quality, "76-100" points good sleep quality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Music Application in people with Sleep Quality and Behçet Disease, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozlem Canbolat, Assistant Professor (+903122162686, ozlemcanbolat@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richard - Campbell Sleep Questionnaire (time frame: a day before the music application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.